Advocacy at a Glance

Top-Line: The Alliance announces a post-election webinar on November 23 and a webinar with CDRH Director Shuren on December 3. As described in this week’s Analysis and Commentary, FDA will likely see an increase of about $40 million in FY 21 funding, spread primarily across six program initiatives. The Biden HHS transition team has been named. The Alliance is sending 2021 dues invoices to members this week and next.

Reminder to Media: Friday Update (including the Advocacy at a Glance and Analysis and Commentary sections) is on-the-record. Further, we are always available to both our members and media to answer additional questions. 

Progress on Appropriations; How Much Progress is Unclear. The full Senate Appropriations Committee released all 12 appropriations bills, including Agriculture-FDA on November 10. Even though the committee has not formally approved these bills, they are expected to be used to negotiate a final set of funding bills with the House of Representatives. Going forward, both Speaker Pelosi and Leader McConnell have said they want to complete an omnibus appropriations bill before the end of the year. While the committees remain hopeful of completing action, resolving the many differences between House and Senate bills is a difficult task. 

The current Continuing Resolution runs through December 11, so possible options include: (1) action on funding bills has to be completed by that time, or (2) another short term CR could be passed to allow additional time to finish the FY 21 package, or (3) a longer-term CR will be adopted to take us into a new Congress, and Administration. Possibly running in parallel, Speaker Pelosi and Leader McConnell have recently said they continue to hope to complete another COVID relief bill, but substantial differences remain.  Where the White House is on this issue at this time is an open question. The general prognosis is that the chances of completing action on the COVID-19 relief bill are slim, notwithstanding that the omnibus appropriations bill might be a handy vehicle.

FDA Likely to See $40 Million Increase for FY 2021. The Senate FY 21 Ag/FDA appropriations bill has now been released. It provides a $43 million increase in program initiatives for cross-cutting, medical product, and food safety activities requested by the Administration. Note: the Committee counts this as a $38 million increase because they have accepted an FDA proposal to save $5 million by not extending a supposedly one-time program.
 
The Senate proposed funding levels for FDA are similar to the Administration’s request and the House-passed numbers. Unless there is a full-year Continuing Resolution -- which would flat-fund the agency at FY 20 levels -- it is reasonable to assume the agency will receive about a $40 million increase for FY 21. Based on the President’s request and the House and Senate bills, there are some specific initiatives that are likely to be funded. Those are discussed in this week’s Analysis and Commentary.

Upcoming Alliance Webinars:

• November 23 at 2:00 p.m. ET: "FDA Regulation and Healthcare Policy in A Post-Trump World," a special post-election webinar featuring Kate Rawson, a senior editor at Prevision Policy LLC who has more than 20 years of experience covering the FDA and its regulated industries.
• December 3 at 2:00 p.m. ET: “CDRH Priorities,” a webinar with Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health. He will be addressing CDRH’s priorities and resource needs. We have asked him to specifically address the Center’s digital health initiatives.

To sign-up to participate in either event, please contact Reed. The events are limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven.

Biden Transition Team for HHS Announced. In an earlier Analysis and Commentary (here), we discussed the stages of Presidential transition that apply whether the President is new or entering a second term. One of the post-election steps is to announce the transition teams for each federal department. Here are the names of the individuals who will serve as President-elect Biden’s HHS transition team.

Invoices for Alliance 2021 Dues Being Mailed This Month. If you are a member and have not received an invoice by November 20, please let us know. While we believe that most of our members have sustained no or little loss in revenue due to the pandemic, we are aware that a few have been severely affected. If this is your case, please contact Steven to discuss how to continue your membership.